Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Mashhad University of Medical Sciences.
Recruitment status was  Active, not recruiting
University of Tehran
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
First received: July 24, 2008
Last updated: July 28, 2008
Last verified: July 2008
The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.

Condition Intervention Phase
Oral Aphthae
Drug: Prednisolone
Drug: Colchicine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae

Resource links provided by NLM:

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • frequency of ulcers [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prednisolone Drug: Prednisolone
5MG Prednisolone per day for 3 months
Active Comparator: Colchicine Drug: Colchicine
0.5 MG Colchicine per day for 3 months

Detailed Description:
Treatment of recurrent aphthous stomatitis (RAS) remains, to date, empirical and non-specific. The main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Confirmation of clinical diagnosis of aphthae
  • Having the experience of oral aphthae at least once in a month
  • Two weeks wash out periods after the last treatment

Exclusion Criteria:

  • History of any systemic disease
  • Using drugs which affect immune system
  • Pregnancy and breast feeding
  • Aphthous related syndromes
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00723268

Iran, Islamic Republic of
Mashhad Dental school
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
Sponsors and Collaborators
Mashhad University of Medical Sciences
University of Tehran
  More Information

Additional Information:
Responsible Party: Mashhad University of Medical Science, Mashhad Dental Research Center
ClinicalTrials.gov Identifier: NCT00723268     History of Changes
Other Study ID Numbers: 286293 
Study First Received: July 24, 2008
Last Updated: July 28, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:
Oral ulcers

Additional relevant MeSH terms:
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Gastrointestinal Agents
Gout Suppressants
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 25, 2016